Four cisplatin lots with 2025 expiration dates from Qilu Pharmaceutical will be imported to the U.S. with the help of Apotex, a Canadian drugmaker. Each lot is a 50 milligram/50 milliliter solution.
“The cisplatin injection from Qilu is marketed and manufactured in China and is not FDA-approved,” according to a Qilu document for healthcare workers. “Only Qilu or its distributor, Apotex Corp., is authorized by the FDA to import or distribute Qilu’s cisplatin injection in the United States.”
Cisplatin treats bladder cancer, squamous cell head and neck cancer, cervical cancer, lung cancer, osteosarcoma, esophageal cancer, adrenal cortex carcinoma, breast cancer, endometrial cancer and liver cancer. It went into shortage in February, and U.S. drugmakers recently said they expect their supply to rebound in June.
FDA Commissioner Robert Califf, MD, tweeted June 2 the agency is working to also support stock levels of carboplatin, another oncology drug in shortage.
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